Theralase Technologies Inc. V.TLT

BTD and pre-BTD overview

[N0taP00p]

While we wait, a useful link with additional YouTube links to detailed examples for oncology.  From 2015, but should still give an idea of how BTD requests progress and what is needed.
https://www.brookings.edu/events/breakthrough-therapy-designation-exploring-the-qualifying-criteria/

[N0taP00p]

According to the details from 8 years ago, pre-BTD seems to be a 15 minute phone call with an expert FDA panel with no more than 2 pages of info. If you look at the bullet points, TLT should have already covered all of those under the fast track umbrella.  Maybe they still want companies to follow this process to weed out incompleteness, or validate that the prior assertions made are still

[FGPstock]

  yea, seems like they screwed up again.... in their nov 2022 nr saying they were applying for btd in q4 2022, there was no mention of any pre-btd process and we all started the 60 day clock. Many said Dr Vera left Tlt because she already delivered on the btd and accomplished her task, but it seems she may have been frustrated at tlt

[DJDawg]

I'm not sure what you mean be screwup. The BTD process always has had a pre-BTD check in. It is on the FDA website as an opportunity to review the details and clarify if ready for BTD. It is a good thing as the person doing the pre-BTD look over knows more about what would be accepted or not accepted and can tell you what to do to optimize success of application.

[Lesalpes29]

FGP here trying to mislead people again? Shame on you FGP... 

[FGPstock]

I am misleading or tlt is? See below, from 11 months ago. 2) Break Through Designation Update. In 2021, Theralase® completed its first significant milestone of Study II by enrolling and treating 25 patients. The Company will compile a clinical data report for submission to the FDA in support of the grant of a BTD approval after completion of the 450 assessments for 25 patients, expected in

[DJDawg]

I see what you mean. Management incompetence more than outright misleading is the usual explanation with TLT. Tlt's motto should be "For the science, invest, despite all the rest"

[TriumphSpitSix]

So the issue with that quote is that it is chock full of ambiguity allowing multiple interpretations. Whether it was intended to mislead I don't know, but they certainly avoided being pinned down on any particular milestone to a stated timeline. Of course, you all likely know "ambiguity" is a standard corporate communications strategy allowing them to make seemingly definite

[O12009]

That maybe when it was discussed with FDA and the first 12 under treated were removed from the data so we had to what until more were treated and reached important milestones?

[Oilminerdeluxe]

My thought too.

[99942Apophis]

FPGstock wrote 2) Break Through Designation Update. In 2021, Theralase® completed its first significant milestone of Study II by enrolling and treating 25 patients. The Company will compile a clinical data report for submission to the FDA in support of the grant of a BTD approval after completion of the 450 assessments for 25 patients, expected in 4Q2022, subject to the CSS’s

[TriumphSpitSix]

2) Break Through Designation Update. In 2021, Theralase® completed its first significant milestone of Study II by enrolling and treating 25 patients. The Company will compile a clinical data report for submission to the FDA in support of the grant of a BTD approval after completion of the 450 assessments for 25 patients, expected in 4Q2022, subject to the CSS’s availability to complete

[FGPstock]

  triumph, if the ceo of a company makes a statement that they expect to apply for btd within 30 day period, ppl should b able to rely on that. Then the new ceo rdw squared told us at the agm he expected to file within "days". I understand to some I am not allowed an opinion unless I am a blind cheerleader, but I think statements like these are reckless and irresponsible. Just an

[Oilminerdeluxe]

He did not say he expected it to be filed. He said it "could" be filed, if memory recalls.. Those attending might know more of this. Obviously things have taken time for one reason or another. Roger is clumsy at times, but I think he follows whatever recommendations are given to him. I would love to hear about BTD being filed, so I hope it happens asap.

[Lesalpes29]

The past is the past no? Noise noise noise! I Look only to the next step, it will 'probably' be BTD followed by AA not too far after. GLTAL 

[Tcwtaeugene2]

   Next step could be anything and there are other means to destroy cancer. This is one but other protocol seams to overcom that one in the future like ARM messenger that big pharma are working whit. So, for me it is just a possibility of succes(this mean dont put all your money on it). Dear prudence is need here. E So sf disapear? Robot?

[Infinity]

I think the PreBTD Is some form of explanation that ir is still Work in progress.  I get it that FDA is not an easy organisation to work without a Lobbyist who is well versed in this area.  TLT Keeps moving their target dates at the expense of credibility.  Hopefully we are very close to BTD and AA.